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CompletedNCT03158623Updated May 18, 2017

Wound Additives in Primary Total Joint Athroplasty

A Phase 3 interventional study of Platelet Rich Plasma and Cellerate in Arthroplasty, Replacement, sponsored by Salt Lake Orthopedic Clinic. Completed. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-18.

Sponsored by Salt Lake Orthopedic Clinic · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Apr 2016, registered May 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

3 cohorts of total joint patient of 30 members each were randomized to receive PRP or Activated Collegen or no additive were studied for status of the wound at 6 weeks and recorded all complications, infections and reoperations. The three groups were than compared for statistical analysis

Read the detailed description

Background: Wound healing remains a concern in primary total joint arthroplasty given the risk of deep infections arising from hematomas, wound separations, and superficial infections. If wound additives can prevent these early complications, their universal application would be cost effective. This study examined whether two wound additives, Platelet-Rich Plasma (PRP) and CellerateRX® (activated collagen), would improve postoperative wound healing and reduce complications in primary total joint arthroplasty.

Methods: A prospective, randomized, controlled study using three cohorts with 30 patients each (Group 1: PRP, Group 2: activated collagen, Group 3: control) were examined postoperatively at two and six weeks, at which time the following data were recorded: six wound measurements, total postoperative blood loss, complications of superficial infections, and reoperations.

02

Conditions studied

  • Arthroplasty, Replacement

Keywords

  • total joint arthroplasty
  • platelet-rich plasma
  • activated collagen
03

In context

Lead sponsor

This is the only study on the registry with Salt Lake Orthopedic Clinic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Osteoathritis of knee and hip

Exclusion criteria

Exclusion Criteria:

  • Inflammatory arthritis and hypercoagulable state
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Platelet Rich Plasma

    30cc of PRP was administered at closure of wound

    Biological: Platelet Rich Plasma

  • Experimental
    Cellerate (Activated Collegen)

    1gm of Cellerate was administered at closure of wound

    Biological: Cellerate

Interventions

  • BiologicalPlatelet Rich Plasma

    Also known as: PRP

  • BiologicalCellerate

    Also known as: Activated college

06

What researchers measure

Primary outcomes

  1. Wound Status

    wound hematoma, dehiscence, superficial infection

    Time frame: 6 weeks post operative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — no plan on sharing data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03158623
Lead sponsor
Salt Lake Orthopedic Clinic
Responsible party
Sponsor
First posted
May 18, 2017
Start date
Apr 1, 2016
Primary completion
Dec 6, 2016
Completion
Dec 20, 2016
Last update
May 18, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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